What RTE says: Abbot bring 800 jobs, have been in éiRe for 75 years and want planning permission for a green field site. But a cursory glance at their violation track record and have they been sued before? uh, yep! 700 million dollars in HealthcareViolations, fraud, Environmental Violations, Government Contracting .... And paying doctors to implant their vascular products. And for Employment Discrimination.
Violation Tracker Abbot Laboratories
"Plant Shutdown
In February 2022, Abbott recalled baby formulas from the market and shutdown their Michigan plant. This is after complaints of infants being sick with serious bacterial infections while consuming formula product made at the Sturgis plant. The recall has caused nationwide shortage of formula milk with at least 73% of baby products out of stock according to data firm Datasembly. In a recent development and with Abbotts' meeting the initial requirement of the U.S. Food & Drug Administration, the facility could start operation and begin production of other special and metabolic formulas in 2–3 weeks time."
In 2021, two of Abbott Laboratories' subsidiaries, Arriva Medical LLC and Alere Inc, had to pay $160M to resolve claims that they had fraudulently billed Medicare for glucose monitors. Supposedly, Arriva used free glucose monitors to entice patients into placing more orders, then took kickbacks on the increased sales. The company was also accused of charging Medicare for glucose monitors given to ineligible patients, including patients who were dead"
Do we want jobs like this?
This is what one member of staff had to say in a letter to the food and drugs authorities:
- The Falsification of Records – On multiple occasions, and in various ways, records have been knowingly falsified. In most but not all of the situations, information of a material nature was not disclosed. This included testing seals on empty cans; signing verifications without adequate knowledge; understating or inaccurately describing events so as to limit or avoid oversight; issuing certifications of projection pages bereft of pertinent data; shipping packages with fill weights lower than represented on the labels; failing to maintain accurate maintenance records; and prematurely removing holds in the absence of all requisite approvals.
- Releasing Untested Infant Formula – The Sturgis site performed a time code removal after the discovery of microorganisms (“micros”) in a batch of infant formula. The remaining portion of the batch outside the time code removal was released without additional testing. On another occasion product was not re-called from the market even after management became aware of a nonconformity (“NC”).
- The 2019 FDA Audit – Active efforts were undertaken and even celebrated during and after the 2019 FDA audit to keep the auditors from learning of certain events believed to be associated with the discovery of micros in infant formula at the Sturgis site.
- Clean-in-Place Staffing and Practices – The Sturgis site has continued to permit lax practices associated with clean-in-place (“CIP”) procedures. The Sturgis site failed and continues to fail to have staff in place with sufficient training and experience to review CIP charts. Nor are CIP charts regularly reviewed prior to the release of a batch. CIP checklists do not require signatures of those performing the tasks and are not otherwise subject to audit by QS staff.
- Failure to Take Corrective Measures – The Sturgis site has repeatedly failed to undertake reasonable measures to reduce natural or unavoidable defects to the level feasible as mandated by the current Good Manufacturing Practices (“cGMPs”). Deficient testing procedures known to be prone to causing mistakes have not been corrected. The Sturgis site continues to rely on staff with insufficient training and experience to interact with third-party labs (“TPL”).
- Lack of Traceability – The Sturgis site has ongoing problems associated with the traceability of its products. The automatic labeler frequently failed to work properly and led to significant difficulties in retracing product. QS staff never knew with certainty if an affected pallet was retrieved.
Is our county vet a match for this corporation? Bear in mind, the same county vet wanted the major dog pound contract to go to the knacker's lorry, with no address in Ireland who get paid twice over as they could invoice for live and carcass, collection and disposal.
Anyway, if you think there are some important points made here that Kilkenny or Donegal Councils should consider and block planning permission, please copy and paste and send this on.